TriangleNCT01774721 · OUTCOME
Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until the end of treatment (up to 48 months)
What was measured
HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.
Analysis population: Patient reported outcomes (PRO) analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
Groups in this outcome
Dacomitinib
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Gefitinib
Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
| Group | Source count |
|---|---|
| Dacomitinib | 226 |
| Gefitinib | 222 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dacomitinib | 3.8 | Not reported | 2.3 | 4.8 | Not reported |
| Gefitinib | 6.6 | Not reported | 3.8 | 9.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.928
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.483
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1641
- param Type
- Cox Proportional Hazard
- param Value
- 1.173
- statistical Method
- Unstratified Log-rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.928
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.483
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1641
- param Type
- Cox Proportional Hazard
- param Value
- 1.173
- statistical Method
- Unstratified Log-rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.3
- upper Limit
- 4.8
- value
- 3.8
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- 9.3
- value
- 6.6
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 222
- units
- Participants
- description
- HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG000
- title
- Dacomitinib
- description
- Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG001
- title
- Gefitinib
- param Type
- MEDIAN
- population Description
- Patient reported outcomes (PRO) analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
- reporting Status
- POSTED
- time Frame
- Baseline until the end of treatment (up to 48 months)
- title
- Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice